Nonspecific low back pain (NSLBP) is a very common condition in different group of population including health care workers. Several noninvasive treatments have been proposed for treatment of NSLBP. One of the treatments is called taping. Kinesio Taping (KT) has been widely used in clinical practice. However, it is unknown whether this type of tape is more effective than placebo taping in patients with chronic lower back pain. The aim of the present study is to observe the effect of Kinesio taping as add on therapy with traditional management of NSLBP.
Seventy male and female patients with CNSLBP will be randomly divided into two groups. Intervention group (n=35): Kinesio tape at lumbosacral region, weekly for 4 weeks. kinesiotapes will be provided from Darco company, black version & tension about 1.4 times will be apply with the H method. Patient will continue the usual care as well. Control group (n=35): Same tape will be used without any tension as placebo. Patient will continue the usual care as well. The intervention sessions for both groups will be weekly for four weeks. Outcomes will be assessed at beginning, end of week four and end of month three for pain severity as primary outcome using VAS and activities of daily living (ADL) as secondary outcome using the Roland-Morris Disability.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016080618257N1
Registration date:2017-09-27, 1396/07/05
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-09-27, 1396/07/05
Registrant information
Name
Amin Azhari
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1802 2353
Email address
azharia@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Mashhad University of Medical Sciences
Expected recruitment start date
2016-09-15, 1395/06/25
Expected recruitment end date
2017-04-15, 1396/01/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of kinesiotape with placebo on chronic nonspecific low back pain among health care workers
Public title
Effect of taping on back pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patient' s age should be between 18-60; Has low back pain for more than 3 month; Without history of surgery on lumbosacral region; Should work in health care field; Without history of important reason for pain such as inflammation, fractures or malignancies; Without clinical feature indicative of roots involvement; Without history of physical therapy in last 6 month; Without history of previous taping.
Exclusion criteria: Patient's unwillingness to continue the study; Patient use a new kind of treatment during the study;Without allergic dermatitis on lumbosacral region .
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Random number table will be use for randomization process
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics commitee of Mashhad University of Medical Sciences
Street address
Qoreishi building, Administration Center, Daneshgah St, Mashhad
City
Mashhad
Postal code
91388-13944
Approval date
2016-05-11, 1395/02/22
Ethics committee reference number
IR.MUMS.fm.REC.1394.500
Health conditions studied
1
Description of health condition studied
Low back pain
ICD-10 code
M54.5
ICD-10 code description
Low back pain
Primary outcomes
1
Description
Pain Severity
Timepoint
At the beginning, at the end of 4th week, at the end of 3th month
Method of measurement
Visual Analoug Scale
Secondary outcomes
1
Description
Activity of Daily living
Timepoint
At the beginning, at the end of 4th week, at the end of 3th month
Method of measurement
Roland-Morris Disability Scale
Intervention groups
1
Description
Intervention group: Kinesio tape at lumbosacral region, weekly for 4 weeks. kinesiotapes will be provided from Darco company, black version & tension about 1.4 times will be apply with the H method. Patient will continue the usual care as well.
Category
Rehabilitation
2
Description
Control group: Same tape will be used without any tension as placebo. Patient will continue the usual care as well.